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L-tryptophan produced by fermentation with Corynebacterium glutamicum KCCM80346

L-tryptophan

Details

Publication date
28 November 2023 (Last updated on: 26 February 2024)
Author
Joint Research Centre

Description

In the current application an authorisation is sought under Article 4(1) for L-tryptophan produced by fermentation with Corynebacterium glutamicum KCCM80346, under the category/functional group 3 (c) 'nutritional additives'/'amino acids, their salts and analogues', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for all animal species.
According to the Applicant, the feed additive contains L-tryptophan with a minimum purity of 60 % (w/w). The feed additive is intended to be added directly to compound feed or through premixtures. The Applicant did not propose a minimum or maximum L-tryptophan content in compound feed.
For the determination of tryptophan in the feed additive, premixtures and compound feed the Applicant proposed a ring-trial validated European Union (EU) method applicable for the determination of the free (synthetic and natural) and total (peptide-bound and free) tryptophan in feed using an HPLC method with fluorescence detection (FLD). The method does not distinguish between the amino acid enantiomers. Furthermore, the EURL is aware of another ring-trial validated EN ISO 13904 method based on high performance liquid chromatography with fluorescence detection (HPLC-FLD) which is dedicated for the determination of free tryptophan in commercial products and premixtures (containing more than 2 % (w/w) of tryptophan) and for the determination of free and total tryptophan in compound feed.
Based on the performance characteristics available, the EURL recommends for official control the above mentioned two ring-trial validated methods based on HPLC-FLD to determine tryptophan in the feed additive, premixtures and compound feed.
Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.

Files

  • 28 NOVEMBER 2023
finrep-feed-2022-6311-tryptophan